BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION SARS-COV-2

    MDR report key: 15584035 · Received October 11, 2022

    Report

    Report Number
    2024800-2022-01099
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 11, 2022
    Report Date
    October 11, 2022
    Manufacturer
    HOLOGIC, INC.
    Product Code
    OJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOGS WERE REVIEWED BY HOLOGIC FIELD SERVICE ENGINEER (FSE) AND CONCLUDED THAT THE INCREASE IN POSITIVITY RATES APPEARED TO HAVE BEGUN JUST AFTER A SAMPLE SHIELD MAINTENANCE. HOLOGIC FIELD APPLICATIONS SERVICES (FAS) TESTED ENVIRONMENTAL SWABS FROM THE CUSTOMER¿S PANTHER FUSION INSTRUMENT AND SURROUNDING AREAS WITH THE FUSION SARS-COV-2 ASSAYS PRIOR TO PERFORMING A CLEANING. THE PRE-CLEANING ENVIRONMENTAL RUN RESULTED IN SEVERAL SARS-COV-2 POSITIVE SITES. FAS PERFORMED A THOROUGH DECONTAMINATION OF THE INSTRUMENT AND SURROUNDING AREAS AND COLLECTED ENVIRONMENTAL SWABS. FAS OBSERVED THAT THE SAMPLE SHIELD ON BOARD WAS WARPED REDUCING THE PIPETTOR CLEARANCE OF THE SHIELD RESULTING IN POTENTIAL CONTACT BETWEEN THE SHIELD AND THE SAMPLE TIP. FAS ALSO NOTED THAT ENVIRONMENTAL CONTAMINATION COULD POTENTIALLY BE CAUSED FROM NOT CHANGING GLOVES AND SAMPLES BEING IN CONTACT WITH CLEAN REAGENT PREP AREAS. THE POST-CLEANING ENVIRONMENTAL RUN RESULTED IN NO FURTHER INDICATION OF CONTAMINATION. HOLOGIC DETERMINED THAT PANTHER SN: 03517 IS NO LONGER CONTAMINATED. HOLOGIC ALSO RECOMMENDED REFRESHER AND PROFICIENCY TRAINING FOR THE PANTHER FUSION SYSTEM IN THE HERVEY BAY LABORATORY AND ALL PATHOLOGY QUEENSLAND LABORATORIES TO ENSURE THE EFFICACY OF THE SYSTEM AND OPERATOR EXPERTISE.

    Description of Event or Problem · 0

    CUSTOMER CONTACTED HOLOGIC REGARDING AN INCREASED POSITIVE RATE AND POTENTIALLY DISCREPANT SARS-COV-2 RESULTS PRODUCED BY THE PANTHER FUSION SN (B)(4). CUSTOMER REPORTED THAT THERE WERE 7 ALLEGED FALSE POSITIVE RESULTS. CUSTOMER RETESTED USING A DIFFERENT PLATFORM (ALINITY & GENEXPERT). THE LOT NUMBER OF THE ASSAY USED WAS NOT PROVIDED TO HOLOGIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390973 FUSION SARS-COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID OJR HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown